NCT00204581

Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases

Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%. However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Interleukin-2 (Proleukin)	6-12 MIE/d 3times a week

Timeline

• Start date: 2003-08-01
• Primary completion: 2009-01-01
• Completion: 2009-12-01
• First posted: 2005-09-20
• Last updated: 2011-08-19

Locations

1 site across 1 country: Germany